Complying with the Falsified Medicines Directive

 In Improving Compliance, Pharmacy Information, Regulations and Standards, Simplifying Product Supply

The EU Falsified Medicines Directive (2011/62/EU) (FMD) was adopted by the UK in 2011 and will be implemented on 9th February 2019, when the Delegated Regulation on ‘safety features’ will be mandatory. All new packs of prescription medicines will have two statutory safety features.

FMD safety features for each pack of medicine:

  • A unique identifier (a 2D barcode)
  • A tamper-evident seal.

The 2D barcode is assigned by the manufacturer and it will be scanned at various points in the supply chain (by pharmacies and wholesalers) to verify that the medicine is authentic. At the point the medicine is to be administered or supplied to patients, for instance in hospitals, the product should be decommissioned. This process will require a scanning device, software and connection to a national database of medicines which is run by SecureMed UK.

Implementing FMD in hospitals

Hospitals should be making preparations for compliance with FMD. However, if the UK leaves the EU in March 2019 without a deal, known as ‘Hard Brexit,’ then FMD will not be implemented as the UK will not have access to the European database of medicines, so this needs to be taken into account.

The steps for implementation include:

  1. Inform hospital staff about the requirements of FMD.
  2. Prepare and map the hospital’s process for receiving stock medication, and then verifying and decommissioning it.
  3. Decide on a system solution, and procure the required scanners and equipment.
  4. Register with SecurMed at each site.
  5. Develop policies and procedures and train staff.

Ashtons is fully FMD compliant and we have opted for a standalone system (that sits neatly on any workspace) and runs ‘FMD Connect’. This system solution has been provided by FMD I.T, the UK’s leading standalone FMD compliance software provider:

  • Approved and authorised by SecurMed UK as an FMD systems solution provider
  • Full plug and play compliance is available via their software FMD Connect
  • Management information dashboards
  • Combination of locally hosted software and Cloud technology
  • Cost-effective.

Other FMD system solutions are available. SecurMed UK maintain a list of software providers with further information on their website .

It’s essential that hospitals make progress with their plans for FMD implementation so that they can provide evidence of their compliance with the relevant healthcare regulators.

For information on FMD Connect, visit their website.

If you require further advice on FMD implementation, then please contact customer services on customerservice@ahps.co.uk 

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